A study to evaluate the safety and long-term biomarker effects of RO7269162 in participants at risk for or at the prodromal stage of Alzheimer’s Disease (AD)
- Conditions
- Alzheimer’s DiseaseMedDRA version: 20.0Level: PTClassification code: 10074616Term: Prodromal Alzheimer's disease Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-506183-13-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 262
1. Body Mass Index (BMI) between 18 to 35 kg/m2 inclusive, at screening, 2. Participants must be either cognitively unimpaired or with a diagnosis of MCI due to AD, according to the NIA – AA workgroups on diagnostic guidelines for AD, and/or according to the updated NIA-AA research framework, 3. Clinical Dementia Rating-Global Score (CDR-GS) of 0 or 0.5, 4. Positive amyloid PET scan based on a cut-off of =24 CL units, 5. Availability of a person (referred as a study partner” throughout the protocol) who: (a) has frequent and sufficient contact (e.g., minimum twice a week in-person, via telephone, video calls, by e-mail or other electronic means) with the participant, and is willing and able to provide accurate information regarding the participant’s cognitive and functional abilities, signs the necessary ICF(s), and has sufficient cognitive capacity to accurately report on the participant’s cognitive and functional abilities; (b) is in sufficient good general health to have a high likelihood of maintaining the same level of interaction with the participant and participation in study procedures throughout the duration of the study; and (c) is fluent in the language of the tests used at the study site. Please note that the study partner does not need to be a family member. Every effort should be made to keep the same study partner throughout the study., 6. In case of treatment with symptomatic AD medications, dosing regimen must be stable for at least eight weeks prior to baseline
1. Any medical history or evidence of a condition other than AD that may affect cognition, 2. History or presence of significant cardiovascular conditions and/or significant hematological disease, 3. History or presence of chronic kidney disease and/or impaired hepatic function, 4. Uncontrolled/poorly controlled diabetes, 5. History of or activate inflammatory bowel disease, 6. Have received any passive or active immunotherapy (immunoglobulin) or other long-acting biologic agent that is under evaluation or approved to prevent or postpone cognitive decline administered within 1 year prior to baseline, and/or any other investigational treatment within five half-lives or 16 weeks prior to screening, whichever is longer.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To investigate the safety and tolerability of daily oral dosing of RO7269162 and to assess the effect of daily oral dosing of RO7269162 on brain amyloid accumulation;Secondary Objective: 1. To assess the effect of daily oral dosing of RO7269162 on pharmacodynamic (PD) biomarkers related to Aß metabolism in CSF and plasma, 2. To investigate the pharmacokinetic (PK) of daily oral dosing of RO7269162 (and its metabolite[s] as appropriate) in plasma and CSF;Primary end point(s): 1. Nature, incidence, severity, and outcome of AEs, 2. Changes from baseline in vital signs, ECG parameters, Columbia-Suicide Severity Rating Scale (C-SSRS) and safety laboratory findings, 3. Change from baseline in brain amyloid load, as measured by amyloid PET scan
- Secondary Outcome Measures
Name Time Method Secondary end point(s):1. Change from baseline in Aß37, Aß38, Aß40 and Aß42 in CSF and Aß40 and Aß42 in plasma;Secondary end point(s):2. Plasma concentrations of RO7269162 (and its metabolite[s] as appropriate);Secondary end point(s):3. CSF concentrations of RO7269162 (and its metabolite[s] as appropriate)